Trial Coordinator
| Dyddiad hysbysebu: | 25 Medi 2025 |
|---|---|
| Cyflog: | £37,259.00 i £45,356.00 bob blwyddyn |
| Gwybodaeth ychwanegol am y cyflog: | £37259.00 - £45356.00 a year |
| Oriau: | Llawn Amser |
| Dyddiad cau: | 08 Hydref 2025 |
| Lleoliad: | London, SE5 9RS |
| Cwmni: | NHS Jobs |
| Math o swydd: | Cytundeb |
| Cyfeirnod swydd: | C9213-25-0976 |
Crynodeb
Operational Performance Initiate and coordinate all activities and essential document management during start-up, aiming for a high-quality Investigator Site File (ISF) to support regulatory greenlight and timely site initiation, across both commercial and non-commercial studies. Coordinate, balance, and facilitate activities related to the completion of the Critical Document Package and the Investigational Product (IP) Release Checklist in accordance with ICH GCP, UK regulations, sponsor requirements, and ethical standards. Liaise with sponsors to confirm site readiness by completing and reviewing study-specific Critical Information Sheets, including local and investigator initiation package documents, IRB submission status, payment details, and clinical supply logistics. Coordinate all required document translations during study start-up, ensuring accuracy and timely delivery to maintain progress against the 150-day metric. Work with internal and external stakeholders to ensure rapid, compliant, and high-quality site activation processes, identifying and resolving any obstacles to study initiation. Attend study team meetings and site start-up calls as required to represent the CRF and maintain oversight of study timelines and expectations. Ensure that the entire start-up process remains focused on quality, efficiency, and cost-effectiveness, contributing to improved site delivery performance and King's CRF reputation. Coordinate all aspects of the day to day conduct of clinical trials/studies from set-up to close down in accordance with ICH GCP, NHS Research Governance and, for Clinical Trials of Investigational Medicinal Products (CTIMPs), the EU Directive on clinical trials Administrative Responsibilities Manage the compilation, version control, and filing of essential documents within both electronic and physical Investigator Site Files (ISFs) during the start-up phase. Maintain up-to-date records in internal and national systems (e.g., EDGE, CPMS), ensuring accurate reflection of progress in relation to study approvals, greenlight status, and start-up timelines. Perform timely and accurate data entry of all relevant study start-up activities into tracking systems to ensure performance monitoring and reporting compliance. Liaise with members of research teams and provide on-going advice and support to ensure the smooth conduct of clinical research ensuring compliance with study protocol, and all relevant guidelines, regulations and legislation. Coordinate the receipt, transfer and storage of any clinical materials or biosamples collected during the study in accordance with GCP guidelines. Answer e-mails and/or telephone calls from members of the public/carers/patients regarding research related queries i.e. in regards to a specific illness, how to participate in clinical trials etc. Prepare, submit and manage amendments to essential clinical research documentation. Ensure close-out procedures at sites are performed as required and are archived. Undertake any other duties that may be required from time to time, as are consistent with the responsibilities of the grade and needs of the service. Ability to familiarise with the facilities standard operating procedures (SOPs), including keeping personal training records up to date. Recording patient information on the electronic patient record system (EPIC), including data management and requests. Communication and Representation Act as the primary point of contact for all start-up related queries from internal and external stakeholders. Represent the CRF at internal and external meetings related to study set-up and performance. Provide guidance to investigators and research teams on start-up requirements. Establish and maintain good working relationships with various professionals including members of King's CRF, Trust R&D, investigators and their teams as well as external stakeholders (e.g. REC, MHRA, CLRN, other R&D departments, universities and research teams) and provide them with timely information when required.